Draft Guidance Calculating The Percentage Of Organic .

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 4 of 163.2.2: Single ingredients that are raw agricultural commodities 1Raw agricultural ingredients can be determined by handlers, manufacturers and certifiers tocontribute 100% organic content in a multi-ingredient formulation, even if they are listed as“organic” on a certificate.3.3: When to include or exclude water from the organic calculation for specific ingredientsThe following guidance applies to products that contain added water, specifically, juices, multiingredient formulations such as chicken stock, soy beverages, almond beverages, rice beverages,ready to drink tea/coffee products, or products containing those ingredients.3.3.1 Juices with an FDA Standard of IdentityThe USDA organic regulations at §205.302(a)(2), state “[i]f the liquid product is identified onthe principal display panel or information panel as being reconstituted from concentrates, thecalculation should be made on the basis of single-strength concentrations of the ingredients andfinished product.” In order to ascertain the single strength juice value of a concentrate, the FDAregulations can be consulted at 21 CFR §101.30(h)(1), which provides a table stating theminimum brix 2 levels for various single strength juices. This table is a tool for calculating thequantity of water that can be added to organic juice concentrates to bring them to single strength.This water is considered a part of the organic content of the juice product.See Appendix B for an example calculation of organic juice, when the specific fruit/vegetablejuice has a standard of identity and the single strength brix is listed at 21 CFR §101.30(h)(1).3.3.2 Juices without an FDA Standard of IdentityNot all types of juices are specified in the FDA’s table. Examples include, but are not limited to,aloe vera juice, acai juice, and noni juice. FDA 21 CFR §101.30(h)(2) states “[i]f there is no brixlevel specified in paragraph (h)(1) of this section, the labeled percentage of that juice fromconcentrate in a juice or juice beverage will be calculated on the basis of the soluble solidscontent 3 of the single-strength (unconcentrated) juice used to produce such concentrated juice.”1Raw agricultural commodity. Any food in its raw or natural state, including all fruits that are washed, colored, orotherwise treated in their unpeeled natural form prior to marketing (Federal Food, Drug, and Cosmetic Act, 21.U.S.C. § 321(r)). Substances used for coloring or coating must be permitted as per § 205.605 or § 205.606 of theNational List.2Brix ( bx) is the sugar content of an aqueous solution. One degree brix is 1 gram of sucrose in 100 grams ofsolution and represents the strength of the solution as a percentage by mass. It is determined by a brix refractometer.3Soluble Solid Content or Total Soluble Solids is the sum solids that are in solution. It is a measure of the amountof material remaining after all the water has been evaporated. Soy beverage solids can be measured by arefractometer.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 5 of 16NOP recognizes that specific brix levels are not provided for every type of juice derived fromorganic fruits and vegetables. In order to ascertain the single strength juice value of a fruit orvegetable juice that is not listed in §101.30(h)(1), the certified operation may submit to thecertifier documentation for the organic juice concentrate verifying the soluble solids content ofthe original unconcentrated single strength juice. Such documentation may include aspecification sheet, laboratory results, or similar document, to justify the quantity of water thatcan be added to organic juice concentrates to bring them to single strength. This water isconsidered a part of the organic content of the juice product.See Appendix C for an example calculation of organic juice, when the specific fruit/vegetablejuice does not have a standard of identity and the single strength brix is not listed at 21 CFR§101.30(h)(1).3.3.4 Carbonated BeveragesCarbonated beverages should be calculated based on the weight of ingredients, not their volume.Carbon dioxide (CO2) is an ingredient in the product and not a processing aid. In many cases, theweight of CO2 will be negligible in the formulation. However, in products where very feworganic ingredients are used, it may be necessary for the certifier to verify the weight of CO2added at formulation to confirm that the product meets organic labeling claims.3.3.5 Chicken stock, soy beverages, almond beverages, rice beverages, ready to drinkteas/coffees, and similar products containing added waterFor ingredients and products where there is no FDA standard of identity, the organic percentageshould be calculated using the weight of the organic soluble solid content in the product. Forexample: A certified operator is making organic soup with soy instead of cream and purchasesorganic soy beverage in the form of a soy base and uses this as the foundation of the soup. Soybeverages do not have a standard of identity; therefore the certified operator must calculate theorganic percentage of the soy beverage /soy base using the weight or percentage of the soysolids. A specification sheet, Certificate of Analysis, or similar document from the soy basesupplier may provide this information.See Appendix D for an example calculation of organic soy beverage and for an examplecalculation of organic chicken noodle soup that uses organic chicken broth.It may not be possible to determine a solid content for products such as ready to drink coffees,teas, hydrosols and therefore these ingredients may offer no measurable organic content in amulti-ingredient finished organic product, even though as single ingredient products, they maybe able to make a 100% organic claim. In this case, the ingredient itself may not contribute to theorganic content of a multi-ingredient finished product.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 6 of 163.4: Excluding salt from the organic calculationSalt (sodium chloride) is excluded from the organic calculation of the finished product. Any othertypes of salt, such as potassium chloride or additives to the salt, such as anti-caking agents, needto be listed on the National List at 205.605 or 205.606.The presence of an anti-caking agent (which is on the National List) in salt does not impact theorganic content of a product. Salt is an excluded ingredient. Anticaking agents are ancillarysubstances in the salt and allow the salt to distribute evenly in the product. The quantity ofanticaking agents added to salt is minor (approximately 0.1%) and the quantity of salt added tomost products is also minor; therefore, the additive is unlikely to affect organic content. Salt isexcluded from the final organic percentage calculation. Any minor amounts of anti-caking agentsin the salt are also excluded if they will not result in a final certified “organic” product thatcontains less than 95% total certified organic ingredients or a certified “made with organic(specified ingredients or food groups)” product that contains less than 70% total certified organicingredients.4. ReferencesOrganic Foods Productions Act of 1990, as amended7 U.S.C. §6510. HandlingUSDA Organic Regulations (7 CFR Part 205)7 CFR § 205.2 Terms DefinedPrincipal display panel. That part of a label that is most likely to be displayed, presented, shown,or examined under customary conditions of display for sale.7 CFR § 205.302 Calculating the percentage of organically produced ingredients.NOSB RecommendationsCompliance, Accreditation, and Certification Committee, NOSB Recommendation, “CalculatingPercentage Organic in Multi-Ingredient Products,” April 2013Other Laws and RegulationsFederal Food, Drug, and Cosmetic Act21 U.S.C. § 321(r)) – Definitions; generallyFood and Drug Administration Regulations21 CFR §101.30 - Percentage juice declaration for foods purporting to be beverages that containfruit or vegetable juiceNOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 7 of 16U.S. Food and Drug AdministrationGuidance for Industry: A Food Labeling Guide (6. Ingredient Lists)Document Control: This document supersedes “NOP Policy Memo 11-9,” dated October 31,2011, which is now obsolete.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 8 of 16Appendix AHow to Calculate Products with Multi-Ingredient IngredientsExample spreadsheet 4Instructions:1. Column 1: Write the name of each ingredient, solid and liquid.2. Column 2: List the weight of each ingredient, except added water and salt. In another part ofthe calculation sheet, water and salt added to the final product can be listed by weight or as apercentage, as well as the name of processing aids used to produce the product. Water, saltand processing aids are excluded from the calculation.3. Column 3: For each organic ingredient, list the percentage of organic content in thatingredient. For example,4The calculation forms are only examples to illustrate the guidance and to bring consistency to the industry in howto calculate ingredient formulas for organic products. Certifiers and handlers may use their own preferred formats.Please note that the organic and non-organic percentages in the subtotal may not always equal 100%. Becausepercentages are recorded to the hundredth place subtotal percentages may be in the range of 99.97 – 100%. Also, thepercentage of non-organic ingredients will increase if the organic content that the organic ingredient is providing isless than 100% content.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 9 of 16 if the organic ingredient is a single ingredient product 5 (e.g., organic onions with noother non-organic additives), the percentage of organic content would be 100%. if the organic ingredient is a multi-ingredient product (e.g., organic egg powdercontaining 1% silicon dioxide), the percentage of organic content would be 99% 6.4. Column 4: Lists the percentage of non-organic ingredients in the formula. Although thiscolumn is not required to be completed since the goal is to determine organic content in theproduct.5. Column 5: Lists the percentage of ingredients in the formula that are certified “organic” or“made with organic***”.6. Column 6: Calculates the actual organic percentage 7 of each organic ingredient, and the totalorganic content 8 in the product.To illustrate: The egg powder used as an ingredient in the formula above contains 1% silicondioxide as an anti-caking agent and 0.5% salt. The total weight of egg powder being added to theproduct is 50 lbs. First exclude the salt, which would leave the total weight of the egg powder (minus salt)at 49.75 lbs. At 1% silicon dioxide for 50 lbs. of egg powder, the silicon dioxide weight was 0.5 lbs.Once the salt is removed, the percentage of silicon dioxide in the product increasesslightly to 1.005%, which is not significant in this case. The silicon dioxide makes up .49 lbs. in the product. Therefore the total organicingredients that the egg powder is contributing to the product are 49.26 lbs. In Column 2, you would enter 49.75 (egg powder minus salt). In Column 3 you would enter 99% because 99% of the egg powder is composed oforganic ingredients and 1% is composed of silicon dioxide. Column 5 shows the percentage that the egg power (which includes the silicon dioxide)contributes to the product (i.e., 36.81%). Column 6 shows the actual organic percentage that the egg powder contributes to theproduct (i.e., 36.81 (total ingredient minus salt) x 0.99 (organic content of ingredient,which is 99%) 36.44% (actual organic percentage that the egg powder is contributingto the product).5Note that some single-ingredient ingredients do not contribute 100% organic content. Further information may berequired from the ingredient supplier.6Handlers should provide certifiers with supporting documentation (e.g., written confirmation from the certified supplier ofthe multi-ingredient ingredient) that substantiates the organic content claim for ingredients. Otherwise, the certified multiingredient ingredient should be calculated at exactly 95% or 70% organic content depending on the eligible organicclaim.7In order to get the actual organic ingredient percentage, start with the number in column 3 and divide it by 100.Then multiply that number by the number in column 5. Example, column 3 (95%) / 100 0.95 x column 5 (50) column 6 (47.5).8Round the percentage down to the nearest whole number.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 10 of 16Appendix BHow to Calculate Products with Organic Juice Concentrates(For Juices with a FDA Standard of Identity)Example spreadsheetInstructions:Follow instructions in Appendix A, except:1. In Column 1: For organic juice concentrates, write the name of the type of concentrate on one rowand write the water added to reconstitute the concentrate to single strength on the rowdirectly below. To work out the water content that can be added to bring the concentrate to singlestrength, use the minimum brix level for the type of single-strength juice, which isstated on the FDA table at 21 CFR 101.30(h)(1). Document the approximate quantityof water in weight used to bring juice to the minimum brix. Obtain appropriatedocumentation from concentrate suppliers verifying reconstitution rates and/or brixvalues for concentrate and reconstituted juices.2. In Column 2: List the weight of the water that is added to reconstitute the organic juiceconcentrates. This water is counted as an organic ingredient.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 11 of 16To illustrate: For the Organic Apple Juice Concentrate at 70 Brix in the calculation spreadsheetabove: The brix of organic apple juice concentrate used by organic handler is 70 brix. The brix of original juice before concentration is 11.5 brix, as stated on the FDA table. Add the amount of water to bring the apple juice concentrate to single strength (ex: to11.5 brix). This water can be counted towards the organic ingredient percentage. Referto the spreadsheet above for the example: 800 lbs. of apple juice concentrate 5,488 lbs.water 6,288 lbs. of single strength apple juice with 11.5 brix. Provide product specification sheet or certificate of analysis for organic apple juiceconcentrate that confirms brix of concentrate and/or the reconstitution levels to bringjuice to single strength (ex: 11.5 brix). Provide evidence that water added during the product formulation to reconstitute the juiceis in line with FDA table at 21 CFR 101.30(h)(1).NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 12 of 16Appendix CHow to Calculate Products with Organic Juice Concentrates(For Juices without a FDA Standard of Identity)Example spreadsheetInstructions:Follow instructions in Appendix A, except:1. In Column 1: For organic juice concentrates, write the name of the type of concentrate on one rowand write the water added to reconstitute the concentrate to single strength on the rowdirectly below. To work out the water content that can be added to bring the concentrate to singlestrength:o Obtain calculations from the supplier of the organic concentrate that verifiesthe soluble solids content, the brix level of the original unconcentrated singlestrength juice, or reconstitution levels to reach the single strength brix. Thesoluble solids content will be in weight and the brix is the percentage of solidsin the unconcentrated single strength juice.o Document the approximate quantity of water in lbs. used to bring juice to thesingle strength brix, as stipulated by the supplier.o Obtain appropriate documentation verifying brix values for concentrate andNOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 13 of 16reconstituted juices. See example below using organic acai concentrate.2. In Column 2: List the weight of the water that is added to reconstitute the organic juiceconcentrates. This water is counted as an organic ingredient.To illustrate: For Organic Acai Juice Concentrate at 30 Brix in the calculation sheet The brix of acai concentrate used by the organic handler is 30 brix. The brix before concentration is 3, according to supplier’s product specification. Add amount of water to bring the acai concentrate to single strength (ex: 3 brix). Thiswater can be counted towards the organic ingredient percentage. Refer to the spreadsheetabove for the example: 950 lbs. of acai juice concentrate 8,550 lbs. water 9,600 lbs.of single strength acai juice with 3 brix. Provide a product specification sheet or certificate of analysis for organic acaiconcentrate that confirms brix or soluble solids content of the concentrate and of thesingle strength juice, or the reconstitution rate to bring the concentrate to single strength. Provide evidence that water added during the product formulation to reconstitute the juiceis in line with information from the supplier.NOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 14 of 16Appendix DHow to Calculate Soy, Rice, Almond Beverages andProducts Containing Ingredients such as Broths, Coffee and TeasExample spread sheet #1: Organic Soy BeverageNOP 5037 Calculating the Percentage of Organic Ingredients in Multi-Ingredient ProductsAuthorized Distribution: Public

United States Department of AgricultureAgricultural Marketing ServiceNational Organic Program1400 Independence Avenue S.W.Room 2648-South BuildingWashington, DC 20250NOP 5037Effective Date: December 5, 2016Page 15 of 16Example spreadsheet #2: Organic Chicken Noodle SoupInstructions:Follow instructions in Appendix A, except:1. In Column 1: For products containing ingredients like organic soy base or organic chicken broth,indicate the weight of soluble solids in the ingredient. To work out the water content that needs to be removed from the ingredients:o Obtain calculations from the supplier of the ingredients that verify the solublesolids percentage.o Multiply the total lbs. of the ingredient (in this case, soy

contributing 100% organic content when it is used in a multi-ingredient organic product. See Appendix A for an example calculation for a multi-ingredient product that contains multi-ingredient ingredients, water and salt. 3.2: Calculating the organic content of single-ingredient ingredients, processed or raw .